Opdivo lowers risk of death for gastric cancer patients

Exciting new data were presented at the 2017 Gastrointestinal Cancers Symposium in San Francisco, USA, on pharma major. Bristol-Myers Squibb’s (NYSE: BMY) Opdivo (nivolumab), showing the drug significantly reduced the risk of death in patients with relapsed/refractory advanced gastric cancer.

The ONO-4538-12 study, conducted by Japanese partner Ono Pharmaceutical (TYO: 4528), demonstrated that Opdivo significantly reduced the risk of death by 37% (HR 0.63; p<0.0001) in patients with previously treated advanced gastric cancer refractory to or intolerant of standard therapy, a condition without current standard-of-care treatments.

ONO-4538-12 is a Phase III, randomized, double-blind, placebo-controlled clinical trial evaluating Opdivo’s efficacy and safety in such patients. The primary endpoint of the study is overall survival (OS). Median OS was 5.32 months (95% CI: 4.63 to 6.41) for patients treated with Opdivo, compared to 4.14 months (95% CI: 3.42 to 4.86) (p<0.0001) for those treated with placebo. In addition, the 12-month OS in the Opdivo group was 26.6% (95% CI: 21.1 to 32.4) versus 10.9% (95% CI: 6.2 to 17.0) in the placebo group. Patients treated with Opdivo also experienced an objective response rate of 11.2% (95% CI: 7.7 to 15.6) compared to 0% (95% CI: 0.0 to 2.8) with placebo and a median duration of response of 9.53 months (95% CI: 6.14 to 9.82), which were secondary endpoints.